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A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.

Primary Purpose

Primary Sjögren Syndrome

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Iguratimod
Placebo
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sjögren Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjogren's Syndrome (EULAR SS)
  • ESSDAI score ≥6
  • IgG >16 g/L
  • Positive anti-SS-A/Ro antibody at screening

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Secondary Sjogren's syndrome
  • severe renal or haematological failure, a history of cancer, hepatitis B or C, human immunodeficiency virus, severe diabetes or any other chronic disease or evidence of infection

  • Prior administration of any of the following:

    1. Rituximab in the past 12 months prior to randomization;
    2. Cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide and iguratimod in the past 12 weeks prior to randomization;
    3. Azathioprine, cyclosporin, tacrolimus, sirolimus, sulfasalazine in the past 4 weeks prior to randomization;
    4. live vaccine in the past 12 weeks prior to randomization
  • Corticosteroids: > 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to randomization; Intramuscular, subcutaneous, intravenous, or intra-articular corticosteroids within 4 weeks prior to randomization.

Sites / Locations

  • Peking University People's HospitalRecruiting
  • The First Affiliated Hospital of Xiamen UniversityRecruiting
  • Southern Medical University Nanfang HospitalRecruiting
  • Sun Yat-sen Memorial HospitalRecruiting
  • the Second Affiliated Hospital of Guangxi Medical University
  • Hebei General Hospital
  • the Second Hospital of HeBei Medical UniversityRecruiting
  • the First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
  • Xinxiang Central Hospital
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • The Affiliated Hospitalof Inner Mongolia Medical UniversityRecruiting
  • Jiangsu Province HospitalRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • Jilin Province People's HospitalRecruiting
  • the First Hospital of Jilin University
  • Shandong Provincial Hospital Affliated to Shandong First Medical UniversityRecruiting
  • Qilu Hospital of Shandong University
  • the Shanghai Ninth People's Hospital
  • Tongji Hospital of Tongji University
  • Heping Hospital Affiliated to Changzhi Medical CollegeRecruiting
  • Shanxi Bethune hospital
  • the Second Hospital of Shanxi Medical University
  • the Second Affiliated Hospital of Xi'an Jiaotong University
  • Tianjin First Central HospitalRecruiting
  • Zhejiang Provincial People's Hospital
  • The Second Affiliated Hospital of Jiaxing UniversityRecruiting
  • Ningbo First HospitalRecruiting
  • the First People's Hospital of Wenling
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Iguratimod 1

Iguratimod 2

Iguratimod 3

Placebo

Arm Description

orally 25mg twice a day

orally 20mg twice a day

orally 10mg twice a day

orally twice a day

Outcomes

Primary Outcome Measures

Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. Overall score, which can range from 0 to 123, a higher score indicates more disease activity

Secondary Outcome Measures

Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components. Total Score Range (0 = Best outcome and 10 = Worst Outcome) The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
Change From Baseline in the Unstimulated Salivary Flow
The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Week 12
Change From Baseline in Schirmer's Test
The Mean change from baseline in Schirmer's Test at all measured time points up to Week 12 The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.
Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM)
The change from baseline in the level of immunoglobulin (IgG, IgA, IgM) at all measured time points up to Week 12
Change From Baseline in the level of rheumatoid factor (RF)
The change from baseline in the level of RF at all measured time points up to Week 12
Change From Baseline in the level of B -cell activation factor (BAFF)
The change from baseline in the level of BAFF at all measured time points up to Week 12
Change From Baseline in the level of T/B/NK cell subsets
The change from baseline in the level of T/B/NK cell subsets at all measured time points up to Week 12
Change From Baseline in the level of erythrocyte sedimentation rate (ESR)
The change from baseline in the level of ESR at all measured time points up to Week 12
Change From Baseline in the level of serum complement (C3 and C4)
The change from baseline in the level of serum complement (C3 and C4) at all measured time points up to Week 12

Full Information

First Posted
March 28, 2021
Last Updated
July 16, 2021
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04830644
Brief Title
A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Iguratimod in Patients With Active Primary Sjogren's Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of iguratimod compared to placebo in patients with active primary Sjogren's Syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sjögren Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iguratimod 1
Arm Type
Experimental
Arm Description
orally 25mg twice a day
Arm Title
Iguratimod 2
Arm Type
Experimental
Arm Description
orally 20mg twice a day
Arm Title
Iguratimod 3
Arm Type
Experimental
Arm Description
orally 10mg twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
orally twice a day
Intervention Type
Drug
Intervention Name(s)
Iguratimod
Intervention Description
Iguratimod orally twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo orally twice a day
Primary Outcome Measure Information:
Title
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Description
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. Overall score, which can range from 0 to 123, a higher score indicates more disease activity
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Description
The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components. Total Score Range (0 = Best outcome and 10 = Worst Outcome) The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
Time Frame
Week 12
Title
Change From Baseline in the Unstimulated Salivary Flow
Description
The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Week 12
Time Frame
Week 12
Title
Change From Baseline in Schirmer's Test
Description
The Mean change from baseline in Schirmer's Test at all measured time points up to Week 12 The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.
Time Frame
Week 12
Title
Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM)
Description
The change from baseline in the level of immunoglobulin (IgG, IgA, IgM) at all measured time points up to Week 12
Time Frame
Week 12
Title
Change From Baseline in the level of rheumatoid factor (RF)
Description
The change from baseline in the level of RF at all measured time points up to Week 12
Time Frame
Week 12
Title
Change From Baseline in the level of B -cell activation factor (BAFF)
Description
The change from baseline in the level of BAFF at all measured time points up to Week 12
Time Frame
Week 12
Title
Change From Baseline in the level of T/B/NK cell subsets
Description
The change from baseline in the level of T/B/NK cell subsets at all measured time points up to Week 12
Time Frame
Week 12
Title
Change From Baseline in the level of erythrocyte sedimentation rate (ESR)
Description
The change from baseline in the level of ESR at all measured time points up to Week 12
Time Frame
Week 12
Title
Change From Baseline in the level of serum complement (C3 and C4)
Description
The change from baseline in the level of serum complement (C3 and C4) at all measured time points up to Week 12
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjogren's Syndrome (EULAR SS) ESSDAI score ≥6 IgG >16 g/L Positive anti-SS-A/Ro antibody at screening Exclusion Criteria: Pregnancy or breast feeding Secondary Sjogren's syndrome severe renal or haematological failure, a history of cancer, hepatitis B or C, human immunodeficiency virus, severe diabetes or any other chronic disease or evidence of infection Prior administration of any of the following: Rituximab in the past 12 months prior to randomization; Cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide and iguratimod in the past 12 weeks prior to randomization; Azathioprine, cyclosporin, tacrolimus, sirolimus, sulfasalazine in the past 4 weeks prior to randomization; live vaccine in the past 12 weeks prior to randomization Corticosteroids: > 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to randomization; Intramuscular, subcutaneous, intravenous, or intra-articular corticosteroids within 4 weeks prior to randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lai Zhiqiang
Phone
+86-18697190725
Email
laizhiqiang@simcere.com
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanguo Li
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guixiu Shi
Facility Name
Southern Medical University Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yang
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingqian Mo
Facility Name
the Second Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiling li
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengxiao Zhang
Facility Name
the Second Hospital of HeBei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongtao Jin
Facility Name
the First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Shi
Facility Name
Xinxiang Central Hospital
City
Xinxiang
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenqiang Fan
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengyun Liu
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fen Li
Facility Name
The Affiliated Hospitalof Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Tie
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Gu
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingyun Sun
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Chen
Facility Name
the First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Jiang
Facility Name
Shandong Provincial Hospital Affliated to Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongsheng Sun
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaxiang Liu
Facility Name
the Shanghai Ninth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Futao Zhao
Facility Name
Tongji Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Tang
Facility Name
Heping Hospital Affiliated to Changzhi Medical College
City
Changzhi
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiping Gong
Facility Name
Shanxi Bethune hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liyun Zhang
Facility Name
the Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxia Wang
Facility Name
the Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyi Li
Facility Name
Tianjin First Central Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wufang Qi
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasong Li
Facility Name
The Second Affiliated Hospital of Jiaxing University
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiao Ye
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiudi Wu
Facility Name
the First People's Hospital of Wenling
City
Wenling
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjun Cheng
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Sun

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.

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